MELAseal 100 “economic” - Mediq Danmark A/S
MELAseal 100 “economic” - Mediq Danmark A/S
MELAseal 100 “economic” - Mediq Danmark A/S
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Operating Manual<br />
Package Sealing Device<br />
<strong>MELAseal</strong> ® <strong>100</strong> <strong>“economic”</strong><br />
Dear Doctor:<br />
since SN 03<strong>100</strong>N1981<br />
Thank you very much for the trust which you have shown by purchasing this package sealing device.<br />
For more than 55 years now, MELAG — a medium-sized family-owned and -operated business —<br />
has specialized in the production of sterilization equipment for medical practice. During this period,<br />
420,000 MELAG units sold throughout the world testify to the exceptional quality of our sterilizers.<br />
This package sealing device has also been produced and tested in accordance with the strictest<br />
quality criteria. Please read the operating Instructions. Careful use and maintenance will ensure that<br />
our product has a long working life and maintains its value.<br />
The staff and management of MELAG<br />
We reserve the right to make technical alterations
Content:<br />
1 INSTALLATION ..........................................................................................................................................3<br />
1.1 Overview of appliance..........................................................................................................................3<br />
1.2 Power cable and pressure lever...........................................................................................................3<br />
1.3 Sealing temperature.............................................................................................................................3<br />
1.4 Wall mounting.......................................................................................................................................4<br />
2 EVERY-DAY USE .......................................................................................................................................4<br />
2.1 Sealing procedure ................................................................................................................................4<br />
2.2 Packaging cutter ..................................................................................................................................4<br />
2.3 Working with packaging rolls................................................................................................................5<br />
3 ACCESSORIES ..........................................................................................................................................5<br />
3.1 Unit-mounted reel dispenser "comfort" ................................................................................................5<br />
3.2 Wall-mounted reel dispenser ...............................................................................................................6<br />
3.3 Reel dispenser “standard”....................................................................................................................6<br />
4 SERVICING.................................................................................................................................................6<br />
4.1 Exchanging the pressure rail................................................................................................................6<br />
4.2 Exchanging or turning the cutting blade...............................................................................................7<br />
5 GERMAN DIN REGULATIONS ..................................................................................................................7<br />
5.1 Width of sealed seams and clear space ..............................................................................................7<br />
5.2 Storage life ...........................................................................................................................................8<br />
5.3 VDE regulations ...................................................................................................................................8<br />
6 SPARE PARTS...........................................................................................................................................8<br />
Illustration:<br />
Illustration 1: Overview of appliance.............................................................................................................. 3<br />
Illustration 2: Bottom of the unit Illustration 3: Mounting on the wall ............................................................. 4<br />
Illustration 4: Working with packaging rolls.................................................................................................... 5<br />
Illustration 5: Fastening the unit-mounted reel dispenser "comfort" .............................................................. 5<br />
Illustration 6 Wall-mounted reel dispenser ................................................................................................... 6<br />
Illustration 7 <strong>MELAseal</strong> ® <strong>100</strong> reel dispenser "standard"................................................................................ 6<br />
Illustration 8 Views of the unit for Service..................................................................................................... 7<br />
Page 2 of 8
1 Installation<br />
Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />
1.1 Overview of appliance________________________________________________<br />
8 7 6<br />
1<br />
2<br />
5<br />
4<br />
3<br />
Illustration 1: Overview of appliance<br />
1 Cutter 5 Knob for temperature regulation<br />
2 Handle 6 Paper guide<br />
3 Main switch 7 Upper rear enclosure hood<br />
4 Signal lamp 8 Upper enclosure front<br />
1.2 Power cable and pressure lever________________________________________<br />
The power cable should be plugged into a 230 V (or only for device variant 110V), 50/60 Hz safety socket<br />
with earthing.<br />
Then switch the power on (Illustration 1 item 3). The <strong>MELAseal</strong> ® <strong>100</strong> will now warm up for about 3 minutes,<br />
and is ready for use when the signal lamp (Illustration 1 item 4) is no longer illuminated.<br />
The pressure handle (Illustration 1 item 2) can be inserted at either the bottom right or bottom left side of the<br />
appliance.<br />
1.3 Sealing temperature _________________________________________________<br />
The <strong>MELAseal</strong> ® <strong>100</strong> has a very precise regulation system for the sealing temperature, which is adjusted by<br />
turning the temperature knob (Illustration 1, item 5). With the transparent packaging material such as<br />
MELAfol ® most commonly used in autoclaves by doctors and dentists (one side paper and one side foil, as<br />
described in DIN 58953 Part 4) the temperature knob (Illustration 1 item 5) should be set to the first third of<br />
the area marked with "MELAFOL". Turning the knob anti-clockwise lowers the heating power, and turning<br />
clockwise increases it. As long as the same packaging material is being used, it is then not necessary to<br />
adjust the sealing temperature again during the sealing operations.<br />
With use of see-through sterilization packaging, the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device always<br />
produces uniform sealing seams with a width of 10 mm (DIN 58953 requires at least 8 mm). This requires,<br />
however, that the operator place the paper side downward onto the sealing rail. Tubular film materials should<br />
not be used, because they tend to adhere to the sealing rail.<br />
Page 3 of 8
!<br />
!<br />
1.4 Wall mounting ______________________________________________________<br />
The <strong>MELAseal</strong> ® <strong>100</strong> "economic" has been prepared for installation on the wall. Use the prepared holes in the<br />
bottom, which you can open by breaking out the metal parts. Use a screw, for example, to break out the<br />
metal plugs toward the outside (see Illustration 3), by gently moving them back and forth at the already<br />
perforated places (Illustration 2, no. 9 + 10). The interval between the holes on the wall is 16.4 cm. Caution:<br />
Be sure to place the device only on walls that are strong enough to support the weight of the unit – and make<br />
sure to use 6 mm wall anchor plugs in the holes, as well as round-head screws (∅ 3.5 mm × 45 mm).<br />
Illustration 2: Bottom of the unit Illustration 3: Mounting on the wall<br />
2 Every-day use<br />
2.1 Sealing procedure ___________________________________________________<br />
When the signal lamp (Illustration 1 item 4) is no longer illuminated you can begin to produce seals.<br />
Warning: The sealing rail is always hot!<br />
Feed in the transparent sterilisation packaging with the paper side downwards. Place the sterilization<br />
package, with the paper side down, under the rear paper guide. Then move the package toward the front<br />
between the pressure bar (top) and the sealing rail (bottom). The sealing pressure is generated by pressing<br />
down the handle (Illustration 4 item 2) until it engages. This ensures that the sealing pressure is maintained<br />
automatically.<br />
Warning: If the handle (Illustration 4 item 2) is not pressed down far enough, sealing pressure may not be<br />
adequate and the quality of the seal can suffer. The handle (Illustration 4 item 2) should not be released<br />
while the seal is being produced, which takes about 4 seconds. The process is terminated by returning the<br />
lever to the vertical starting position, and sealing can be repeated as required, if the main switch is not<br />
switched off.<br />
2.2 Packaging cutter ____________________________________________________<br />
The cutting blade (Illustration 8 item 14) must be dragged quickly and with light pressure across the foil using<br />
the black cutter handle (Illustration 4 item 1), and with the switch handle (Illustration 4 item 2) pressed as far<br />
as it will go. If the blade is moved too slowly then the sterilisation packaging will not be cut properly but will<br />
only wrinkle up. The cutting blade functions when moved to the right and to the left.<br />
Page 4 of 8<br />
9 10
Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />
2.3 Working with packaging rolls__________________________________________<br />
As shown in Illustration 4, slide the rolls onto the roll mounting rod, position them with the side guides<br />
(Illustration 4 item 20), move the packaging under the rear angled paper guide (Illustration 1 item 6), and<br />
guide them through toward the front, between the sealing rail and the pressure bar. The paper side must be<br />
downward: i.e., it must lie on the sealing rail (down). Then pull the packaging in the required length toward<br />
the front, seal the package, and then cut it off.<br />
Place the objects to be sterilized in the package that you have now made. Guide the open end from the front<br />
between the sealing rail and the pressure bar, and seal the package. The width of the sealing rail enables<br />
you to work with packages up to a width of 250 mm.<br />
1<br />
Illustration 4: Working with packaging rolls<br />
3 Accessories<br />
3.1 Unit-mounted reel dispenser "comfort" _________________________________<br />
The "Comfort" unit-mounted roll-holder (Illustration 4 & Illustration 5) - MELAG item number. 111 - can be<br />
used to save space by mounting the rolls of sterilisation pack directly onto the <strong>MELAseal</strong> ® <strong>100</strong> Package<br />
Sealing Device. The roll-holders come with four side guides (Illustration 4, item 20), which ensure good<br />
guidance of the sterilization packaging rolls. The roll-holder is attached to the rear side of the sealing device<br />
with keyhole borings and brackets (Illustration 5 and Illustration 8 item 13 & 19).<br />
Illustration 5: Fastening the unit-mounted reel dispenser "comfort"<br />
2<br />
20<br />
13<br />
19<br />
Page 5 of 8
!<br />
!<br />
3.2 Wall-mounted reel dispenser __________________________________________<br />
Illustration 6 Wall-mounted reel dispenser<br />
Page 6 of 8<br />
If the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device is<br />
placed against the wall, or if it is mounted directly<br />
on the wall, then it is best to have a wall-mounted<br />
reel dispenser - MELAG item number. 106,<br />
(Illustration 6) - positioned directly above it. The<br />
wall-mounted roll-holder can also be installed in a<br />
wall cupboard above the package sealing device,<br />
and the packaging foil fed through a slit in the<br />
base of the cupboard.<br />
Four (4) side guides are provided for each reel<br />
dispenser, to ensure proper positioning of the rolls<br />
of sterilization packaging.<br />
3.3 Reel dispenser “standard” ____________________________________________<br />
The reel dispenser "standard" – MELAG item number 110 – can be used to hold the packaging role directly<br />
on the <strong>MELAseal</strong> ® <strong>100</strong> Package Sealing Device. This reel dispenser is fixed on the two mounting points on<br />
the rear side of the package sealer (Illustration 7 and Illustration 8 item 13).<br />
Illustration 7 <strong>MELAseal</strong> ® <strong>100</strong> reel dispenser "standard"<br />
4 Servicing<br />
Wall<br />
4.1 Exchanging the pressure rail __________________________________________<br />
Note: Let the appliance cool down first to avoid risk of burns. Then disconnect the appliance from<br />
the mains power supply. This is important for all repairs, maintenance and servicing work.<br />
Loosen the four Phillips screws at the top (Illustration 8 item 11 & 12), and completely remove only the two<br />
screws at the rear (item 12).<br />
Now lightly lift the upper enclosure front (Illustration 1 item 8) and remove the upper rear enclosure hood<br />
(Illustration 1 item 7) toward the rear.<br />
Danger! The cutting blade is very sharp! (Illustration 8 item 14)<br />
Take off the blade holder by unscrewing the two Phillips screws (Illustration 8 item 18) from the blade handle.<br />
The pressure rail (Illustration 8 item 15) is now visible. Now remove the right and the left sides of the<br />
enclosure (they are attached by Velcro-type closures). Unscrew the right and the left studs on the end of the<br />
pressure rail (Illustration 8 item 16), and pull the pressure rail out of the unit to the rear.<br />
Replace the pressure rail, and install it by following the above steps in reverse order.
!<br />
!<br />
Operating manual <strong>MELAseal</strong> ® <strong>100</strong><br />
Install the blade holder and the upper rear enclosure hood again. Be sure to slide the front enclosure hood<br />
(Illustration 8 item 17) in the direction of the arrow. Make sure that the axis of the cutter carriage runs free<br />
and easily in the slot of the cover.<br />
11<br />
17<br />
12<br />
13<br />
19<br />
Illustration 8 Views of the unit for Service<br />
4.2 Exchanging or turning the cutting blade_________________________________<br />
Note: Let the appliance cool down first to avoid risks of burns. Then disconnect the appliance from<br />
the mains power supply. This is important for all repairs, maintenance and servicing work.<br />
Loosen the four Phillips screws at the top (Illustration 8 items 11 & 12), and completely remove only the two<br />
screws at the rear (item 12).<br />
Now lightly lift the upper enclosure front (Illustration 1 item 8) and remove the upper rear enclosure hood<br />
(Illustration 1 item 7) toward the rear.<br />
Danger! The cutting blade is very sharp! (Illustration 8 item 14)<br />
Remove the screw that holds the cutting blade (Illustration 8 item 14). Turn or replace the blade, and fasten it<br />
tightly in place with the screw.<br />
Install the upper rear enclosure hood again. Be sure to slide the front enclosure hood (Illustration 8 item 17)<br />
in the direction of the arrow. Make sure that the axis of the cutter carriage runs free and easily in the slot of<br />
the cover.<br />
5 German DIN regulations<br />
14<br />
5.1 Width of sealed seams and clear space _________________________________<br />
Width of sealed seams<br />
German Standard DIN 58953 Part 7 requires that sealed seams in transparent packaging material should<br />
have a width of at least 8 mm. With a width of 10 mm for its sealed seams, the <strong>MELAseal</strong> ® <strong>100</strong> is<br />
considerably better than this minimum requirement.<br />
DIN 58953 Part 7 specifies that a clear space of at least 30 mm be left below the sealing border between the<br />
sterilisation goods and the seam in order to ensure a perfect seal without wrinkles. This applies both for bags<br />
and transparent material from the roll.<br />
General:<br />
• Do not select packages that are too small.<br />
• Before sealing the packages, make sure to press them together to remove as much air as possible.<br />
• If you wish to seal entire standard tray cassettes, the length of the film package should be at least twice<br />
as long as the standard tray cassette (also see DIN 58953, Part 7). This also applies to the sterilization of<br />
textiles in standard tray cassettes.<br />
18<br />
15<br />
16<br />
Page 7 of 8
5.2 Storage life _________________________________________________________<br />
Guidelines for the length of storage for sterile medical products<br />
Sterile goods packaging Type of packaging storage<br />
unprotected 1)<br />
Paper bags in accordance<br />
with DIN 58 953 Part 4 and heat<br />
resistant and self-sealing<br />
transparent packaging or hoses<br />
made of paper or plastic in<br />
accordance with<br />
DIN 58953 Part 5 or other<br />
equivalent packaging<br />
Sterile goods in single<br />
packaging or twostage<br />
packaging<br />
Sterile-goods store<br />
packaging not opened<br />
or opened and closed<br />
again<br />
Serves as supply for<br />
immediate usage.<br />
Avoid this way of<br />
storage.<br />
Length of storage<br />
5 years 4)<br />
Storage<br />
protected 2)<br />
6 months 3)<br />
1) in accordance with 4.3 a) in DIN 58953-8: 1993-02<br />
2) in accordance with 4.3 b) in DIN 58953-8: 1993-02<br />
3) Exceeding the length of storage for this type of packaging is not recommended for practical and<br />
economical reasons<br />
4) provided that no other maturity was defined by the manufacturer<br />
A comment on the table in Section 8.2 of the DIN standard says:<br />
"The information in the table only represents standard values. These do not mean that longer storage<br />
periods are not possible under particularly favourable storage conditions, or that a longer duration of storage<br />
necessarily leads to the pack contents being re-contaminated during storage, but signify that if these periods<br />
are observed, recontamination of the contents when they are opened and correctly removed is extremely<br />
unlikely."<br />
An additional explanatory note goes into further detail:<br />
"The risk in storing sterile goods is not that micro-organisms may penetrate the sterile goods packaging,<br />
provided that dry storage conditions are ensured and the packaging material has the required germ-proof<br />
qualities, but that when the sterile goods packaging is opened after storage, micro-organisms contained in<br />
dust particles may be stirred up and could re-contaminate the sterile objects when these are removed.<br />
"The extent of dust loading depends upon the dust content of the air and on the duration of storage. For<br />
these reasons the storage period should be kept as short as possible."<br />
5.3 VDE regulations _____________________________________________________<br />
In accordance with current VDE regulations, this appliance is not suitable for use in areas at risk of<br />
explosion.<br />
It should only be serviced by the manufacturer or a specially authorised agent (dealer or customer service).<br />
6 Spare parts<br />
Article Description<br />
10115 Pressure rail<br />
12630 Overheating protection switch<br />
31190 Heating cartridge (up to SN 04<strong>100</strong>N1620)<br />
13680 Heating cartridge (since SN 04<strong>100</strong>N1621)<br />
33730 Main switch<br />
17780 Cutting blade<br />
Article Description<br />
45615 Blade holder<br />
45605 Handle for cutter<br />
59610 Temperature regulation<br />
14405 Knob for temperature regulation<br />
24130 Signal lamp<br />
Page 8 of 8 Rev.: 3 – 08/1313 BA_3_GB_seal<strong>100</strong>eco_abSN03<strong>100</strong>N1981.doc